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临床试验/NCT05490186
NCT05490186
终止
不适用

Function, Pain, and Alignment Following Knee Replacement for the Treatment of Osteoarthritis

North York General Hospital1 个研究点 分布在 1 个国家目标入组 261 人2021年11月16日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Knee Replacement, Total
发起方
North York General Hospital
入组人数
261
试验地点
1
主要终点
Function
状态
终止
最后更新
11个月前

概览

简要总结

There are many factors that can influence patient satisfaction and patient related outcomes following total knee replacement including the surgical alignment of the joint components. Historically, total knee replacements have been performed with an aim aiming to achieve neutral alignment or a mechanical weight axis in the lower extremity . However, only 0.1 % of the population have a pre-surgical anatomical neutral alignment, and therefore the constitutional anatomy of the patient is neglected. There is a growing trend to return patients back their anatomical constitutional alignment after a knee replacement, referred to as Kinematic Alignment using robotics. The aim of this randomized controlled trial is to examine how mechanical alignment and kinematic alignment impacts function, pain, mood and fatigue following TKR for the treatment of osteoarthritis. Outcomes will be measured at 6 week, 6 months, 1 year and 2 years after surgery.

注册库
clinicaltrials.gov
开始日期
2021年11月16日
结束日期
2024年2月8日
最后更新
11个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Mary Rahmat

Clinical Trials Manager

North York General Hospital

入排标准

入选标准

  • undergoing unilateral TKR for the treatment of osteoarthritis
  • between the age of 18 and 85 years of age
  • able to read, speak and understand English, have a telephone
  • are able to provide consent

排除标准

  • enrolled in another study, are
  • undergoing revision surgery or bilateral surgery, and are
  • over the age of 85 years. Patients will also be excluded if they
  • have a cognitive impairment (as indicated in the medical record) affecting their ability to comprehend the questions being asked

结局指标

主要结局

Function

时间窗: post-operatively 1 year

Oxford knee score

次要结局

  • Function(post-operatively at 2 years)
  • Pain intensity and effectiveness of analgesics(Post-operatively at 2 years)
  • Quality of Life following knee surgery(post-operatively at 1 year)
  • Satisfaction with knee surgery(Post-operatively at 2 years)

研究点 (1)

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